title: Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).
abstract: BACKGROUND
  The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated.
  
  
  OBJECTIVE
  To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks.
  
  
  METHODS
  A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed.
  
  
  RESULTS
  A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups.
  
  
  CONCLUSIONS
  Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
  
  
  BACKGROUND
  clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.
authors.affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Ubiratan C
authors.initials: UC
authors.lastname: Adler
authors.forename: Stephanie
authors.initials: S
authors.lastname: Krüger
authors.forename: Michael
authors.initials: M
authors.lastname: Teut
authors.forename: Rainer
authors.initials: R
authors.lastname: Lüdtke
authors.forename: Lena
authors.initials: L
authors.lastname: Schützler
authors.forename: Friederike
authors.initials: F
authors.lastname: Martins
authors.forename: Stefan N
authors.initials: SN
authors.lastname: Willich
authors.forename: Klaus
authors.initials: K
authors.lastname: Linde
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
mesh_terms: D003710:Demography; D003863:Depression / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006705:Homeopathy / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D010919:Placebos